Da Vinci Xi Surgical System

System, Surgical, Computer Controlled Instrument

Intuitive Surgical, Inc

The following data is part of a premarket notification filed by Intuitive Surgical, Inc with the FDA for Da Vinci Xi Surgical System.

Pre-market Notification Details

Device IDK170713
510k NumberK170713
Device Name:Da Vinci Xi Surgical System
ClassificationSystem, Surgical, Computer Controlled Instrument
Applicant Intuitive Surgical, Inc 1266 Kifer Road Sunnyvale,  CA  94086
ContactBrandon Hansen
CorrespondentCindy Domecus
Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough,  CA  94010
Product CodeNAY  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-09
Decision Date2017-06-13
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.